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Roche
Roche
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Roche is a global healthcare and pharmaceutical company focused on advancing patient care through research and development, digital innovation, and collaboration. With a workforce of more than 101,000 employees, the company brings together expertise across technology, manufacturing, business strategy, and other functions that support healthcare innovation. Roche highlights diversity, equity, and inclusion across its international teams and offers career pathways for experienced professionals, students, and graduates, including opportunities connected to its operations in Germany, Austria, and Switzerland.
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Roche Regulatory Affairs Manager, IVD Instruments and Software

Lead regulatory submissions and strategy for Roche Diagnostics’ IVD instruments and software. Support product approvals across global markets, with a focus on Pathology and Digital Pathology.

USUnited StatesAZArizonaNJNew Jersey
$106,100 – $197,000 / year
HybridFull-timeMiddleSeniorEnglish RequiredCompliance

Description

  • Coordinate regulatory projects for laboratory instruments, consumables, software, and integrated systems.
  • Support the Pathology and Digital Pathology portfolios within the Pathology Customer Area.
  • Oversee regulatory documents and submission dossiers for complex products and programs.
  • Develop and manage portions of global regulatory submissions and registration plans.
  • Apply US FDA requirements to IVD instruments, software, accessories, and system reagents.
  • Work with external leaders, customers, and other stakeholders.
  • Build external partnerships and apply stakeholder management practices.
  • Assist with audit preparation, execution, and follow-up.
  • Guide organizational adaptation to changing regulatory requirements.
  • Interpret regulator perspectives and apply regional regulatory strategies.
  • Develop strategies that address obstacles and support worldwide product approvals.
  • Collaborate with stakeholders to identify and deliver solutions.
  • Address challenges and opportunities with input from collaborators.
  • Build relationships that help shape Roche’s direction and its products.
  • Make independent decisions and proactively initiate work.
  • Demonstrate VAAC Leadership and agility while supporting an inclusive environment.
  • Unite colleagues around shared goals, resolve conflict, and improve team outcomes.

Requirements

  • Bachelor’s or master’s degree in life sciences, data science, or a related field, or equivalent experience.
  • An advanced degree is preferred.
  • Experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals with significant regulatory affairs experience: 3–5 years with a PhD, 5–7 years with a master’s degree, or 6–8 years with a bachelor’s degree, or equivalent.
  • Demonstrated experience with Daily Management and Continuous Improvement practices.
  • Knowledge of European, US, Chinese, and other international regulations.
  • Ability to interpret and implement quality standards is an advantage.
  • Ability to manage complex work and parts of global projects.
  • Experience with medical laboratory instruments, accessories, consumables, and software launch strategies in the US, EU, and other global markets is preferred.
  • Must live near Tucson, Indianapolis, Branchburg, or Carlsbad.
  • Relocation assistance is not available.

Benefits

  • A discretionary annual bonus may be offered based on individual and company performance.
  • Benefits information is available at the provided link.
  • Roche is an equal opportunity employer.
  • Accommodation is available for applicants with disabilities during the online application process.

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